Events

Device Recall Henry Schein Explorer 2 D/E 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hu-Friedy Mfg Co, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    28672
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0832-04
  • 사례 시작날짜
    2004-03-29
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32315
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Explorer, Operative - Product Code EKB
  • 원인
    Reports of breakage on some dental explorers were received by the own label distributor and forwarded to hu-friedy mfg. co. (importer of record & spec. setter). investigation conducted by hu-friedy mfg. co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.
  • 조치
    On 3/29/04, Hu-Friedy Mfg. Co. notified Henry Schein, Inc. of the recall by telephone. This was followed up with a letter on 4/2/04. Henry Schein initiated a sub-recall to its customers by sending recall letters and response forms (dated 3/31/04) by First Class Mail on 4/2/04 & 4/5/04. The mailing will be followed up with fax, e-mail or phone calls.

Device

Device Recall Henry Schein Explorer 2 D/E
  • 모델명 / 제조번호(시리얼번호)
    Date Codes/Lot Numbers: 1102, 0103 (1102 represents November 2002, & 0103 represents January 2003); Product Code/Mfr. Part Code 101-0913.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The products were sold to the sole direct account: the Own Label Distributor, Henry Schein, Inc. in Melville, NY. Henry Schein further distributed the explorers to end users nationwide and internationally. Henry Schein Divisions located in Canada, Spain, France, Germany, United Kingdom, Holland, and New Zealand who further distributed the explorers to their customers in Canada and abroad.
  • 제품 설명
    HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701.
  • Manufacturer
    Hu-Friedy Mfg Co, Inc.

Manufacturer

Hu-Friedy Mfg Co, Inc.
  • 제조사 주소
    Hu-Friedy Mfg Co, Inc., 3232 N Rockwell St, Chicago IL 60618-5944
  • Source
    USFDA